United Medical Industries Co. , Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “United Medical Industries Co. , Ltd.” (first 2004, latest 2007), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 99 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 4 | 4 |
| GAL | Suture, Absorbable, Natural | 1 | 1 |
| GAP | Suture, Nonabsorbable, Silk | 1 | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 1 | 1 |
Review panels
Most recent United Medical Industries Co. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072646 | UNICAPRONE | GAM | 2007-11-07 | 50 |
| K072645 | UNIGLACTIN | GAM | 2007-11-07 | 50 |
| K072644 | UNICRYL QUICK | GAM | 2007-11-07 | 50 |
| K042287 | UNIPLAIN & UNICHROM | GAL | 2005-09-07 | 379 |
| K042288 | UNICRYL | GAM | 2004-12-27 | 125 |
| K042285 | UNICRYL M | NEW | 2004-12-10 | 108 |
| K042284 | UNIMIDE | GAR | 2004-12-03 | 101 |
| K042286 | UNIESTER C | GAT | 2004-12-01 | 99 |
| K042283 | UNIPRO | GAW | 2004-12-01 | 99 |
| K042282 | UNISILK | GAP | 2004-12-01 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named United Medical Industries Co. , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- United States Surgical, A Division of Tyco Healthc (218 510(k)s)
- United States Endoscopy Group, Inc. (94 510(k)s)
- United Orthopedic Corporation (61 510(k)s)
- United Biotech, Inc. (22 510(k)s)
- United Consortium (15 510(k)s)
- United Diagnostics, Inc. (12 510(k)s)
- United Surgical Corp. (7 510(k)s)
- United Pacific Co., Ltd. (6 510(k)s)
- United Dental Mfg., Inc. (5 510(k)s)
- United Medical Systems, Inc. (5 510(k)s)
- United Sonics, Inc. (5 510(k)s)
- United Medical (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under United Medical Industries Co. , Ltd.?
FDA lists 10 510(k) clearances under the applicant name “United Medical Industries Co. , Ltd.” (first 2004, latest 2007), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by United Medical Industries Co. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name United Medical Industries Co. , Ltd. is 99 days.
Which FDA product codes appear under United Medical Industries Co. , Ltd.?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 4); GAL (Suture, Absorbable, Natural, 1); GAP (Suture, Nonabsorbable, Silk, 1).
Next steps
- See all 10 United Medical Industries Co. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GAM, United Medical Industries Co. , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.